| TGA Action ID |
RC-2026-RN-00644-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Neoss Guide Implant Inserters
Catalogue Number: 51240
Batch Number: 200674
Date of Manufacture: 27/07/2026 |
| ARTG Number |
352800 |
| Unique Device Identifier (UDI) |
05060440337499 |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class III |
| Reason for the Action |
The guide inserters were produced with incorrect laser marking. The physical product is showing ‘S SP’. The correct platform ‘N NP’ is identified on the product label.
The incorrect laser marking could potentially cause the user to incorrectly identify the instrument and select an NP inserter for use with an SP implant. Use of the NP inserter with an SP implant is considered highly unlikely to cause any deformation or damage to the implant. |
| Instructions for Customers/Users |
Customers are to:
- Inspect your stock, identify any affected guide inserters of batch number 200674.
- If alternative batches are available or the Guide Inserter is not required for any upcoming surgery, quarantine affected stock.
- If alternatives are unavailable and the Guide Inserter is required for an upcoming surgery, refer to the product label for the correct platform. Place the inserter in the surgical tray in the designated N NP placeholder. Before use, clean and sterilize the product as described in the applicable Instructions for Use (IFU).
Replacement products are expected to be available from the end of September. When replacements are available, please return affected stock on hand or organise with sales representatives to receive replacement stock. |
| Action Commencement Date |
24/08/2026 |
| Responsible Entity |
|
| Contact Information |
0434 427 220 - Ellie McKenzie, Neoss Australia |